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J&J's (JNJ) Bladder Cancer Drug Gets FDA's Breakthrough Tag
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Johnson & Johnson (JNJ - Free Report) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its pipeline candidate, TAR-200, for the treatment of high-risk non-muscle-invasive bladder cancer.
TAR-200 is an intravesical delivery system being developed for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), for patients who are ineligible for, or decline, radical cystectomy, which means surgical removal of the bladder.
The BTD is based on data from the phase IIb SunRISe-1 study. The study evaluated TAR-200 alone as well as in combination with J&J’s investigational PD-1 monoclonal antibody, cetrelimab, in the above-mentioned patient group.
Data from the study presented at the European Society for Medical Oncology showed that treatment with TAR-200 led to a 77% complete response rate in the above-mentioned patient group.
J&J’s stock has declined 10.1% so far this year against an increase of 4.8% for the industry.
Image Source: Zacks Investment Research
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
J&J believes TAR-200 treats localized bladder cancer by a novel interventional approach for which the treatment options available now are limited and involve surgical removal of the bladder. Thus, it believes TAR-200 has potential to transform the treatment of bladder cancer, which justifies the BTD granted to the drug.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.19 to $2.62 over the past 60 days. Estimates for 2024 have jumped from $2.54 per share to $3.07 over the same timeframe. NVO’s stock has surged 49.1% year to date.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.
Estimates for Puma Biotech’s 2023 earnings per share have increased from 67 cents to 72 cents over the past 60 days. Estimates for 2024 have jumped from 55 cents per share to 62 cents over the same timeframe. PBYI’s stock has declined 10.2% year to date.
Earnings of Puma Biotech beat estimates in three of the last four quarters, missed in one, delivering an earnings surprise of 76.55% on average.
In the past 30 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents per share. During the same period, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year to date, shares of CTMX have declined 10%.
CTMX’s earnings beat estimates in three of the last four quarters, missed in one, delivering an earnings surprise of 45.44% on average
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J&J's (JNJ) Bladder Cancer Drug Gets FDA's Breakthrough Tag
Johnson & Johnson (JNJ - Free Report) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its pipeline candidate, TAR-200, for the treatment of high-risk non-muscle-invasive bladder cancer.
TAR-200 is an intravesical delivery system being developed for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), for patients who are ineligible for, or decline, radical cystectomy, which means surgical removal of the bladder.
The BTD is based on data from the phase IIb SunRISe-1 study. The study evaluated TAR-200 alone as well as in combination with J&J’s investigational PD-1 monoclonal antibody, cetrelimab, in the above-mentioned patient group.
Data from the study presented at the European Society for Medical Oncology showed that treatment with TAR-200 led to a 77% complete response rate in the above-mentioned patient group.
J&J’s stock has declined 10.1% so far this year against an increase of 4.8% for the industry.
Image Source: Zacks Investment Research
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
J&J believes TAR-200 treats localized bladder cancer by a novel interventional approach for which the treatment options available now are limited and involve surgical removal of the bladder. Thus, it believes TAR-200 has potential to transform the treatment of bladder cancer, which justifies the BTD granted to the drug.
Zacks Rank & Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold).
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
Some better-ranked drug/biotech companies worth considering are Novo Nordisk (NVO - Free Report) , Puma Biotech (PBYI - Free Report) and CytomX Therapeutics (CTMX - Free Report) , all with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.19 to $2.62 over the past 60 days. Estimates for 2024 have jumped from $2.54 per share to $3.07 over the same timeframe. NVO’s stock has surged 49.1% year to date.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.
Estimates for Puma Biotech’s 2023 earnings per share have increased from 67 cents to 72 cents over the past 60 days. Estimates for 2024 have jumped from 55 cents per share to 62 cents over the same timeframe. PBYI’s stock has declined 10.2% year to date.
Earnings of Puma Biotech beat estimates in three of the last four quarters, missed in one, delivering an earnings surprise of 76.55% on average.
In the past 30 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents per share. During the same period, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year to date, shares of CTMX have declined 10%.
CTMX’s earnings beat estimates in three of the last four quarters, missed in one, delivering an earnings surprise of 45.44% on average